The goal of this trial is to collect long-term observational data on the tolerability, safety and efficacy of dabigatran etexilate in a spectrum of patients receiving bileaflet mechanical heart valves. All patients that have completed study 1160.113…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
There are no primary or secondary efficacy and safety variables. Clinical
efficacy and safety outcome variables, mortality and morbidity endpoints will
be evaluated in an exploratory manner and are described in Section 5.3.1.1 and
5.3.2.1. other endpoints.
Secondary outcome
See Sections 5.3.1.1 and 5.3.2.1 of the protocol for other endpoints.
Background summary
This study is an extension trial to the phase II study RE-ALIGN (study number
1160.113). It is designed to evaluate the long-term safety of dabigatran
etexilate in patients who have received bileaflet mechanical heart valve
replacement in the aortic and/or mitral position. Given the heterogeneity of
the heart valve patient population and the complexity of optimal dosing, a long
term observation of the safety of dabigatran etexilate in comparison to
standard of care therapy with warfarin is warranted. With this trial all
patients of the RE-ALIGN trial will be given the opportunity to continue on
their treatment until the possible registration of dabigatran etexilate in this
indication or if it is concluded that registration will not be pursued.
Study objective
The goal of this trial is to collect long-term observational data on the
tolerability, safety and efficacy of dabigatran etexilate in a spectrum of
patients receiving bileaflet mechanical heart valves. All patients that have
completed study 1160.113 should be offered the opportunity to continue their
treatment for an extended period in this study.
Study design
It is a prospective, open label, active comparator trial with blinded endpoint
adjudication.
Intervention
Patients will have successfully completed 1160.113 prior to inclusion into this
study. Patients will remain on the treatment arm to which they were randomised
in RE-ALIGN and receive either warfarin (maintained within the appropriate INR
range) or dabigatran etexilate (same dose as at the end of 1160.113).
Study burden and risks
In order to monitor for these risk factors, data will be scrutinised on an
ongoing basis by an independent external data safety monitoring board (DSMB)
(no representative from the Sponsor will participate in their closed
discussions). All data (for both dabigatran etexilate and warfarin patients),
both adjudicated and non adjudicated will be reviewed by the DSMB in an ongoing
fashion.
The study will be conducted under the guidance of an Operations Committee who
will have an overall supervisory function. The use of electronic data capture
should ensure quick turnaround times and up to date data for the independent
DSMB to provide an unbiased review of data in a timely manner. Additionally,
all bleeds and thromboembolic events will be reviewed by an Independent
Adjudication Committee (IAC); data will be provided in discrete patient
packets, removing data which could potentially provide information on the
patients drug assignment (INR values for example) in order to ensure the IAC
review is conducted in a blinded fashion.
Comeniusstraat 6
Alkmaar 1817 MS
NL
Comeniusstraat 6
Alkmaar 1817 MS
NL
Listed location countries
Age
Inclusion criteria
1. Male and female patients aged over18 and below or equal 75 years at time of inclusion into 1160.113.
2. The patient must be able to give informed consent in accordance with ICH GCP guidelines and local legislation and/or regulations.
3. Continuing need for anticoagulation.
Exclusion criteria
1. Active infective endocarditis.
2. Uncontrolled hypertension (systolic blood pressure (SBP) >180mm Hg and/or diastolic blood pressure (DBP) >100mm Hg) as measured at baseline for this study (Visit 1).
3. Need for continued treatment with ticlopidine, ticagrelor, prasugrel, systemic ketoconazole, itraconazole, cyclosporine, tracrolimus, dronedarone, rifampicin, phenytoin, carbamazepine, St. John*s Wort or any cytotoxic/myelosuppressive therapy. See Section 4.2.2.
4. Recent malignancy or radiation therapy (since inclusion into 1160.113) unless the malignancy was a basal cell carcinoma that was completely removed.
5. Pre-menopausal (last menstruation <=1 year prior to screening) who:
• Are pregnant or nursing or
• Are not surgically sterile or
• Are of child bearing potential and not practising an acceptable method of birth control, or do not plan to continue practising an acceptable method of birth control throughout the trial (highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly [R09-1292].
6. Patients not willing or able to comply with the protocol requirements or considered unreliable by the Investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration, have a life expectancy less than the expected duration of the trial due to concomitant disease or have any condition which, in the opinion of the Investigator, would not allow safe participation in the study (e.g. drug addiction, alcohol abuse).
7. Previous participation in this study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-002285-21-NL |
| CCMO | NL37360.060.11 |
| Other | nog niet toegekend |